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Purpose

This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients must be a man or woman of at least 18 years of age. - Patients must have Stage II/Stage III rectal cancer or Stage II (high risk)/Stage III colon cancer per AJCC 2017 that has been surgically totally resected (R0 confirmed by pathology report). Stage II (high risk) colon cancer is defined as Stage II disease with any of the following risk factors for recurrence: - T4 - Grade ≥ 3. - Clinical presentation with bowel obstruction or perforation. - Histological signs of vascular, lymphatic or perineural invasion. - < 12 nodes examined. - Patients must have detectable ctDNA prior to start of adjuvant chemotherapy (AdCTx) (except for the Biomarker Cohort). • ctDNA assay must be performed through this trial or study BNT000-001 ctDNA screening protocol. - Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. - Patients must have adequate hematologic and organ function. - Adequate tumor material in formalin-fixed paraffin embedded (FFPE) blocks or as sectioned tissue (only upon approval by sponsor) must be available (as described in the laboratory manual). - The patient has started a standard of care AdCTx within 8 weeks post-surgery and has completed at least 3 months of treatment of a 3 or a 6 month course of chemotherapy (including rest days).

Exclusion Criteria

  • Patients with uncontrolled intercurrent illness. - Diagnosed microsatellite instability (MSI) high tumors. - Prior therapy with any of the following: - Neo-adjuvant (radio)chemotherapy prior to surgery. - Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of trial treatment or anticipation of need for systemic immunosuppressive medication during trial treatment, with the exception of low dose steroids defined as 10 mg oral prednisone (or equivalent). - Current or recent (within the 28 days prior to randomization) treatment with another investigational drug. - Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy. - Patients who developed metastatic disease during screening/receiving standard of care treatment (not applicable for Exploratory Cohort). - Patients with known past or current malignancy other than inclusion diagnosis, except for: - Cervical carcinoma of Stage 1B or less. - Non-invasive basal cell or squamous cell skin carcinoma. - Non-invasive, superficial bladder cancer. - Prostate cancer with a current PSA level < 0.1 ng/mL. - Any curable cancer with a complete response (CR) of > 2 years duration. - Patients with known allergies, hypersensitivity, or intolerance to RO7198457 or its excipients. - Patients who had major surgery (e.g., surgery requiring general anesthesia) within 4 weeks before screening, or will not have fully recovered from surgery, or have surgery planned during the time the patient are expected to participate in the trial. - Patients with active hepatitis B or C. - Patients who have a history of human immunodeficiency virus (HIV) antibody positivity, or tests positive for HIV at screening. - Patients who have had prior splenectomy.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
RO7198457 		Participants will receive a recommended dose of RO7198457.
  • Drug: RO7198457 intravenous (i.v.)
    RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.
Other
Observational Group 		Observational group will undergo watchful waiting, which is the standard of care in this setting.
  • Other: Observational group (no intervention)
    watchful waiting
Experimental
Biomarker Cohort 		15 patients
  • Drug: RO7198457 intravenous (i.v.)
    RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.
Experimental
Exploratory Cohort 		20 patients
  • Drug: RO7198457 intravenous (i.v.)
    RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.

Recruiting Locations

University of Kansas Cancer Center
Westwood, Kansas 66205

More Details

Status
Recruiting
Sponsor
BioNTech SE

Study Contact

BioNTech clinical trials patient information
+49 6131 9084
patients@biontech.de

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.